Happy New Year! In case you missed them, here are our five most popular posts from 2018. This has been an exciting year for the Finnegan IP FDA Blog, and we look forward to sharing IP FDA news with you in 2019.

  1. FDA Final Guidance on E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - This was the most popular post in 2018, covering FDA's March 2018 updates to the original ICH E6(R1) Good Clinical Practice guidance. The final guidance primarily focuses on quality management and monitoring of clinical trials, updating the original guidance based on advances in the use of electronic data recording and reporting.
  2. FDA Final Guidance on Bioanalytical Method Validation - This post was second most popular, covering FDA's final guidance in May 2018 about elements of bioanalytical method development and validation that are needed to ensure the quality of an assay and the reliability of the data it generates. Similar to the most popular post, this guidance updates an earlier guidance based on advances in science and technology.
  3. USPTO Issues Memorandum on Recent Subject Matter Eligibility Decision: Vanda Pharm. Inc. v. West-Ward Pharm. – This post was third most popular, covering the USPTO's memorandum on patent eligibility. The June 2018 memorandum provides examination guidance based on the CAFC Vanda decision, which held that claims to methods of treatment that included "arguably conventional genotyping and treatment steps" were patent eligible. The memo emphasizes that method of treatment claims that practically apply natural relationships can be patent eligible.
  4. FDA Draft Guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products - This post was fourth most popular, covering FDA's July 2018 draft guidance on general principles to consider when drafting the indications and usage section of a drug or biological product label. The guidance identifies what information to include; when to include additional descriptors, limitations, or qualifiers; and how to format the information within the section.
  5. CAFC Affirms District Court Decision Finding Unclean Hands in Gilead v. Merck – This post was fifth most popular, covering the CAFC's affirmance of a district court's judgment that Merck's business and litigation misconduct rendered its patents unenforceable under the unclean hands doctrine.

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